Cleared Traditional

K110645 - BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K110645 · Sonosite,Inc. · Cardiovascular device
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Jun 2011
Decision
91d
Days
Class 2
Risk

K110645 is an FDA 510(k) clearance for the BIO Z CARDIO PROFILE HEMODYNAMIC MONITOR. Classified as Plethysmograph, Impedance (product code DSB), Class II - Special Controls.

Submitted by Sonosite,Inc. (Bothell, US). The FDA issued a Cleared decision on June 3, 2011 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2770 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sonosite,Inc. devices

Submission Details

510(k) Number K110645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2011
Decision Date June 03, 2011
Days to Decision 91 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DSB Plethysmograph, Impedance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSB Plethysmograph, Impedance

All 113
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